Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) (VADT)

This study has been completed.

Sponsor:

Collaborators:

National Eye Institute (NEI)

SmithKline Beecham

Information provided by (Responsible Party):

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT00032487

First received: March 21, 2002

Last updated: March 7, 2014

Last verified: March 2014

Results First Received: September 10, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: Insulin Drug: Glimepiride Drug: Rosiglitazone Drug: Metformin

Participant Flow

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Arm 1/Standard Glycemic Control	Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
Arm 2/Intensive Glycemic Control	Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Standard glycemic control
Total	Total of all reporting groups

Baseline Measures

	Arm 1/Standard Glycemic Control	Arm 2/Intensive Glycemic Control	Total
Number of Participants [units: participants]	899	892	1791
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	606	612	1218
>=65 years	293	280	573
Age [units: years] Mean (Standard Deviation)	60.3 (9.0)	60.5 (9.0)	60.4 (9.0)
Gender [units: participants]
Female	26	26	52
Male	873	866	1739
Region of Enrollment [units: participants]
United States	899	892	1791

Outcome Measures

1. Primary:

Primary Major Macrovascular Events [ Time Frame: Post baseline time to the first major macrovascular event up to 82 months ]

2. Secondary:

Secondary Endpoint [ Time Frame: Post baseline time to first event up to 82 months ]

Serious Adverse Events

Other Adverse Events

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our study had several limitations. Since we were studying veterans, the patients were predominantly men, and extrapolation of our findings to women must be done with caution.Changes in therapeutic agents have occurred since the design of our protocol

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